MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 5.5 EXP VERSE CAN SCR 6.0X40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199725640S

Device Problem Torn Material (3024)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2018, the surgery for l1 burst was performed by using the expedium verse system.The fixed area was th11 ¿ l3.During the final tightening of the outer part of the reported correction key by a torque wrench, it was spinning around.Although the reported correction key was replaced with another one, the same issue occurred.The surgeon stopped using the correction key and switched to the unitized set screw; however, it was spinning around.The surgeon judged that the threads of the reported screw were broken and replaced the screw with another one.The screw had been poly-locked.The surgery was completed with a 10-minute-delay, and there was no adverse consequence to the patient.

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual examination revealed that the threads inside the tulip head were completely peeled off with minor damage to the drive feature.The broken extended tabs were also received.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the torn threads on the 5.5 exp verse scr 6.0x40 cannot be determined.This damage may have occurred due to cross-threading a set screw upon insertion.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 EXP VERSE CAN SCR 6.0X40
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle ; SZ
• MDR Report Key: 7341078
• MDR Text Key: 102729010
• Report Number: 1526439-2018-50239
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034440668
• UDI-Public: (01)10705034440668
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199725640S
• Device Lot Number: 149299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 04/18/2018
• Supplement Dates FDA Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1